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Anadys Pharmaceuticals, Incorporated


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Anadys Pharma reinitiated with "neutral"

www.newratings.com | Oct 21, 2009

NEW YORK, October 21 (newratings.com) - Analysts at Wedbush Morgan reinitiate coverage of Anadys Pharma (ticker: ANDS) with a "neutral" rating. The target price is set to $3. [more]

http://www.newratings.com/en/main/company_headline.m?id=1979339

Anadys Pharmaceuticals to Report Third Quarter 2009 Financial Results

www.prnewswire.com

SAN DIEGO, Oct. 22 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that it will report third quarter 2009 financial results on Thursday, October 29, 2009, after the U.S. financial markets close.

http://www.prnewswire.com/news-releases/anadys-pharmaceuticals-to-report-third-quarter-2009-financial-results-65622812.html

 

Anadys Pharmaceuticals Down 7% Since SmarTrend's Sell Recommendation - Zibb.com

SmarTrend, our proprietary pattern recognition system, called a Downtrend for Anadys Pharmaceuticals (NASDAQ:ANDS) on October 28, 2009 at $2.01.

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Tags: market   nasdaq   pharmaceuticals   profit   securities   trial  

Companies: Anadys Pharmaceuticals Inc (ANDS)

 

Anadys Pharmaceuticals Reports Third Quarter 2009 Financial Results and Program Highlights -

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS), a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C, today reported its financial results and program highlights for the third quarter ended September 30, 2009.

"During the third quarter, we initiated dosing HCV patients in our Phase II combination study of ANA598 and today are announcing the full enrollment of the first cohort in this study," said Steve Worland, Ph.D., President and CEO of Anadys. "We are pleased with the speed of enrollment for the first cohort and maintain our expectation to receive initial 28-day safety and response data from this cohort by year-end. Patients are scheduled to continue receiving ANA598 through 12 weeks, and we expect to receive the remaining on-treatment data from both cohorts in the study during the first half of next year."

Financial Results

As of September 30, 2009, the Company's cash, cash equivalents and securities available-for-sale totaled $25.4 million compared to $27.9 million as of December 31, 2008. The decrease in cash, cash equivalents and securities available-for-sale is the result of year-to-date cash utilization partially offset by proceeds received from a "registered direct" offering of common stock and warrants in early June 2009.

Research and development expenses were $4.0 million for the third quarter of 2009, compared to $7.6 million for the third quarter of 2008. The $3.6 million decrease was primarily attributable to a $1.8 million decrease in ANA598 development costs and a $1.5 million decrease in ANA773 development costs and to a lesser extent cost savings associated with our strategic restructuring initiated in June 2009. During the third quarter of 2008 we incurred a significant increase in development costs associated with our ANA598 program related to our then on-going Phase I healthy volunteer clinical trial, the initiation of long-term chronic toxicology studies and the manufacturing of additional drug substance to support the long-term chronic toxicology studies. ANA598 development costs during the third quarter of 2009 were primarily related to the initiation of our Phase II combination study. ANA773 development costs during the third quarter of 2008 were primarily driven by costs associated with the initiation of our Phase I clinical trial for the treatment of hepatitis C. During the third quarter of 2009, ANA773 development costs were primarily related to close-out costs associated with this trial.

General and administrative expenses were $2.0 million for the third quarter of 2009, compared to $2.1 million for the third quarter of 2008. The $0.1 million decrease primarily resulted from cost savings associated with our strategic restructuring initiated in June 2009.

Operating expenses were $6.0 million for the third quarter of 2009, compared to $9.7 million for the third quarter of 2008. Included as a component of Anadys' operating expenses were non-cash, share-based expenses of $0.6 million and $0.7 million for the third quarter of 2009 and 2008, respectively.

The net loss was $7.7 million for the third quarter of 2009, compared to a net loss of $9.3 million for the third quarter of 2008. Included in the net loss for the third quarter of 2009 is a $1.9 million loss resulting from an increase between June 30, 2009 and September 30, 2009 in the liability associated with common stock warrants issued in conjunction with our "registered direct" financing in early June 2009. Basic and diluted net loss per common share was $0.21 in the third quarter of 2009, compared to $0.32 in the third quarter of 2008. Non-cash share-based expense resulted in a $0.02 and $0.03 increase in basic and diluted net loss per share for the third quarter of 2009 and 2008, respectively.

For the nine months ended September 30, 2009, Anadys reported a net loss of $23.0 million, compared to $23.9 million for the same period last year. Basic and diluted net loss per common share was $0.71 and $0.83 for the nine months ended September 30, 2009 and 2008, respectively.

Development Program Highlights

ANA598

ANA598 is the Company's non-nucleoside HCV polymerase inhibitor currently in Phase II development.

    --  Phase II Combination Study.  Following FDA allowance of the study
        protocol in late July, Anadys commenced dosing in the Phase II
        combination study of ANA598 in early September.  The first cohort in
        this trial is now fully enrolled.  Anadys expects to receive initial
        28-day safety and viral load response data from the first cohort by
        year-end and to receive the remaining on-treatment safety and response
        data from both cohorts in this trial during the first two quarters of
        2010.  In the ongoing Phase II study, treatment-naive genotype 1
        patients are to receive ANA598 or placebo in combination with Pegasys(R)
        (peginterferon alfa-2a) and Copegus(R) (ribavirin, USP), a current
        standard of care (SOC), for 12 weeks at dose levels of 200 mg or 400 mg
        twice daily (bid), each with a loading dose of 800 mg bid on day one.
        After week 12, patients are scheduled to continue to receive SOC alone.
        Patients who have undetectable levels of virus at weeks 4 and 12 will be
        randomized to stop all treatment at either week 24 or 48.  The primary
        endpoint of the study is the proportion of patients who achieve
        undetectable levels of virus at week 12 (complete Early Virological
        Response or cEVR).  Response at week 4 will also be assessed to provide
        the rate of Rapid Virological Response, or RVR.  Patients will be
        followed for 24 weeks after stopping therapy to determine the rate of
        Sustained Virological Response, or SVR.  Approximately 90 patients are
        planned to be enrolled in this study - 30 patients receiving ANA598 and
        15 receiving placebo at each dose level.  The study is being managed by
        the Duke Clinical Research Institute (DCRI) under the leadership of John
        McHutchison, M.D. and is being conducted at a number of clinical sites
        in the United States.
    --  Preclinical Data at AASLD. On Tuesday, November 3, 2009, Anadys will
        present data demonstrating the breadth of in vitro antiviral activity of
        ANA598 against a range of clinical isolates in a poster titled, "ANA598
        Displays Potent In Vitro Antiviral Activity Against Diverse Clinical
        Isolates of Genotype 1 HCV in a Transient Replicon Shuttle Vector
        System," at the 60th Annual Meeting of the American Association for the
        Study of Liver Disease (AASLD) in Boston, MA.

    --  Favorable Toxicology Profile.  In early October, Anadys announced
        complete results from its two long-term, chronic toxicology studies of
        ANA598 (26 weeks duration in rats and 39 weeks duration in monkeys).
        The No Observed Adverse Effect Level, or NOAEL, is 1000 mg/kg, the
        highest dose tested, in both the rat and monkey.  The completed
        toxicology studies support the ongoing Phase II clinical study as well
        as future clinical studies of longer duration.

ANA773

ANA773 is the Company's oral inducer of endogenous interferons that acts via the toll like receptor 7 (TLR7) pathway.

    --  Proof of Concept Achieved in Phase I Clinical Trial in HCV.  In early
        August, Anadys announced viral load data for the final cohort of
        hepatitis C patients in a Phase I clinical trial of ANA773.  In patients
        who received 2000 mg of ANA773 every other day over 10 days, the mean
        (+/- SEM) maximal decline in viral load was 1.3 (+/- 0.4) log10,
        compared to a mean maximal decline of 0.3 (+/- 0.1) log10 in patients
        who received placebo (p=0.037).  Five of the eight patients who received
        2000 mg ANA773 experienced a maximal decline of greater than 1 log,
        while none of the eight patients who received placebo experienced a
        decline of greater than 1 log (p<0.001 for the proportion of patients
        with maximal response greater than 1 log compared to placebo).  The mean
        end-of-treatment decline was 0.6 log10 in patients who received 2000 mg
        ANA773 compared to 0.1 log10 in patients who received placebo.  ANA773
        was well-tolerated in patients throughout the course of the study and
        there were no serious adverse events reported.  On Tuesday, November 3,
        2009, Anadys will present complete results from this study in a poster
        titled, "ANA773, an Oral Inducer of Endogenous Interferons that Acts Via
        TLR7, Reduced Serum Viral Load in Patients Chronically Infected with
        HCV," at the AASLD meeting in Boston, MA.  Anadys believes that ANA773
        holds promise as a potential replacement for injectable interferon
        products in HCV therapy and is seeking partnership opportunities as a
        way to potentially continue advancing the development of ANA773.

Webcast of Conference Call

Anadys will host a conference call at 5:00 pm Eastern Daylight Time today to discuss its third quarter 2009 financial results and highlights and to provide an update on its development programs. A live webcast of the call will be available online at www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 81828355. The webcast and telephone replay will be available through November 12, 2009.

About Anadys

Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines. The Company is developing ANA598, a non-nucleoside polymerase inhibitor for the treatment of hepatitis C. The Company has also investigated the potential of ANA773, an oral, small-molecule inducer of endogenous interferons that acts via the Toll-like receptor 7, or TLR7, pathway in hepatitis C.

Safe Harbor Statement

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to (i) the expectation that Anadys will receive 28-day safety and response data from the first cohort in the ANA598 Phase II study by year-end and additional on-treatment data from both cohorts in the study during the first half of 2010; (ii) the ability for patients to achieve EVR, RVR and SVR in the ANA598 Phase II study; (iii) the belief that ANA773 holds promise as a potential replacement for injectable interferon products in HCV therapy; and (iv) Anadys' ability to obtain a partnership around ANA773 and/or continue the development of ANA773. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. For example, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 will not have unforeseen safety issues or will have favorable results in the Phase II trial. In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into transactions around its product candidates, its ability to successfully develop and market products, difficulties or delays in its preclinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving future products and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2008 and Anadys' Form 10-Q for the quarter ended June 30, 2009. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.


                       Condensed Consolidated Financial Statements

                                Anadys Pharmaceuticals, Inc.
                      Condensed Consolidated Statements of Operations
                          (In thousands except per share amounts)
                                      (Unaudited)

                            Three Months Ended            Nine Months Ended
                              September 30,                 September 30,
                            ------------------            -----------------
                            2009           2008         2009          2008
                            ----           ----         ----          ----

    Operating expenses
       Research and
        development        $4,023         $7,581      $15,546       $19,091
       General and
        administrative      2,023          2,084        6,611         6,104
                            -----          -----        -----         -----
        Total operating
         expenses (1)       6,046          9,665       22,157        25,195

    Interest income and
     other, net               183            316          565         1,311
    Loss from valuation
     of common stock
     warrant liability     (1,869)             -       (1,429)            -
                           ------            ---       ------           ---
        Total other
         income, net       (1,686)           316         (864)        1,311

    Net loss (1)          $(7,732)       $(9,349)    $(23,021)     $(23,884)
                          =======        =======     ========      ========

    Net loss per share,
     basic and
     diluted (1)           $(0.21)        $(0.32)      $(0.71)       $(0.83)
                           ======         ======       ======        ======

    Share used in
     calculating net
     loss per share,
     basic and diluted     37,310         28,775       32,578        28,734
                           ======         ======       ======        ======

    (1) Includes non-cash operating expenses for share based payments of $584
        and $738 or approximately $0.02 and $0.03 effect on basic and diluted
        net loss per common share for the three months ended September 30,
        2009 and 2008, respectively. Research and development expense and
        general and administrative expense includes $287 and $297,
        respectively, of non-cash operating expenses for share based payments
        for the three months ended September 30, 2009. Includes non-cash
        operating expenses for share based payments of $2,330 and $2,065 or
        approximately $0.07 and $0.07 effect on basic and diluted net loss
        per common share for the nine months ended September 30, 2009 and
        2008, respectively. Research and development expense and general and
        administrative expense includes $1,230 and $1,100, respectively, of
        non-cash operating expenses for share based payments for the nine
        months ended September 30, 2009.


                          Anadys Pharmaceuticals, Inc.
                     Condensed Consolidated Balance Sheets
                                (In thousands)

                                                  September 30,  December 31,
                                                     2009           2008
                                                     ----           ----
                                                  (Unaudited)    (Audited)
     Assets

     Cash, cash equivalents and securities
      available-for-sale                            $25,358       $27,936
     Other current assets                             1,112         2,202
     Noncurrent assets                                  807         1,536
                                                        ---         -----
        Total assets                                $27,277       $31,674
                                                    =======       =======

     Liabilities and Stockholders' Equity

     Current liabilities                             $8,988        $5,813
     Other long-term liabilities                         29            36
     Stockholders' equity                            18,260        25,825
                                                     ------        ------
        Total liabilities and stockholders' equity  $27,277       $31,674
                                                    =======       =======

Pegasys(R) and Copegus(R) are registered trademarks of Hoffman-La Roche Inc.

SOURCE Anadys Pharmaceuticals, Inc.

http://www.anadyspharma.com

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Companies: Anadys Pharmaceuticals Inc (ANDS)

 

Anadys Pharmaceuticals Inc. (ANDS) Corporate Event Announcement Notice - Zibb.com

Anadys Pharmaceuticals Inc. (ANDS)
Expected next earnings release:
Announcement date: 10/22/2009 - After Market
Earnings Quarter: Q3
Announcement Status: Unconfirmed

Tags: corporate   earnings   market   pharmaceuticals  

Companies: Anadys Pharmaceuticals Inc (ANDS)

 

Anadys Pharmaceuticals Inc. (ANDS) Corporate Event Announcement Notice - Zibb.com

Anadys Pharmaceuticals Inc. (ANDS)
Expected next earnings release:
Announcement date: 10/22/2009 - After Market
Earnings Quarter: Q3
Announcement Status: Unconfirmed

Tags: corporate   earnings   market   pharmaceuticals  

Companies: Anadys Pharmaceuticals Inc (ANDS)

 

Web Sites

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ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients

www.bio-medicine.org

...Data Being Presented Today at 44th Annual Meeting of EASL ... ...Management to Discuss Study Results and Program Status During Q1 Finan... ...,ANA598,Demonstrates,Potent,Antiviral,Activity,at,all,Dose,Levels,in,Completed,Phase,Ib,Study,in,Hepatitis,C,Patients,medicine,advanced medical

http://www.bio-medicine.org/medicine-technology-1/ANA598-Demonstrates-Potent-Antiviral-Activity-at-all-Dose-Levels-in-Completed-Phase-Ib-Study-in-Hepatitis-C-Patients-4207-1/

Copyright © 2009 MarketWatch, Inc. All rights reserved. Please see our Terms of Use. MarketWatch,...

Copyright © 2009 MarketWatch, Inc. All rights reserved. Please see our Terms of Use. MarketWatch, the MarketWatch logo, and BigCharts are registered trademarks of MarketWatch, Inc. Intraday data provided by Interactive Data Real-Time Services and subject to the Terms of Use.

http://www.holdrs.com/holdrs/main/index.asp?Action=Headlines&Description=&Image=&symb=ANDS&sid=1704604

EvaluatePharma - Anadys Pharmaceuticals Sample Information

EvaluatePharma provides historic and forecast sales from 1986 to 2010 for worldwide and US Rx (prescription drugs) and OTC drugs. EvaluatePharma analysts continuously update company models from SEC filings, annual reports, investor/analyst presentations, company press releases, FDA and USPTO.

http://www.evaluatepharma.com/CoInfo/CoInfo-ANDS.htm

Anadys Pharmaceuticals - Analyst News | newratings.com

Copyright © 2002 - 2008 newratings.com GmbH | Legal | Licensing Quote data provided by IS.eFinance Solutions (powered by IS.Teledata AG) using StandardPoor's ComStock Inc. and others. Delay times are 15 mins for European exchanges and NASDAQ, 20 mins for NYSE and AMEX.

http://www.newratings.com/headlines/Anadys-Pharmaceuticals_US03252Q4082.html

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hepatitis C | oncology | Anadys Pharmaceuticals, Inc.

anadyspharma.com

Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and ...

http://anadyspharma.com/

Contact Us | Anadys Pharmaceuticals, Inc.

www.anadyspharma.com

Anadys Pharmaceuticals, Inc. maintains its corporate headquarters and research and development group in San Diego, California.

http://www.anadyspharma.com/contact/index.html

Anadys Pharmaceuticals Incorporated | ANDS | ANDS | TheStreet.com

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Stay informed on the latest Anadys Pharmaceuticals Incorporated news. TheStreet is the source for financial market and Wall Street news, trading stock and personal finance advice.

http://www.thestreet.com/topic/5907/anadys-pharmaceuticals-incorporated.html

ANDS - Anadys Pharmaceuticals Incorporated | ANDS Stock Quotes ...

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Get the latest ANDS - Anadys Pharmaceuticals Incorporated stock market performance data. TheStreet is the source for financial market news, trading stock, quotes, and personal ...

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News from Zibb.com

Events

Anadys Pharmaceuticals to Present at the Oppenheimer Healthcare Conference

www.bio-medicine.org

...SAN DIEGO Oct. 28 /- Anadys Pharmaceuticals I...The corporate presentation will be simultaneously webcast and can be a... About Anadys ...Anadys Pharmaceuticals Inc. is a biopharmaceutical company dedicated

http://www.bio-medicine.org/medicine-technology-1/Anadys-Pharmaceuticals-to-Present-at-the-Oppenheimer-Healthcare-Conference-5797-1/

Anadys Pharmaceuticals to Present at Two Upcoming Investor Conferences

www.bio-medicine.org

Health,... ... ... ...SAN DIEGO Sept. 3 /- Anadys Pharmaceuticals I...,Anadys,Pharmaceuticals,to,Present,at,Two,Upcoming,Investor,Conferences,medicine,medical news today,latest medical news,medical newsletters,current medical news,latest medicine news

http://www.bio-medicine.org/medicine-news-1/Anadys-Pharmaceuticals-to-Present-at-Two-Upcoming-Investor-Conferences-56234-1/